Abilify Maintena

N/A

Manufactured by Otsuka America Pharmaceutical, Inc.

96,636 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Abilify Maintena

Abilify Maintena is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Otsuka America Pharmaceutical, Inc.. The most commonly reported adverse reactions for Abilify Maintena include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, WEIGHT INCREASED, DRUG INTERACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Abilify Maintena.

Top Adverse Reactions

DRUG INEFFECTIVE4,787 reports
OFF LABEL USE3,514 reports
PRODUCT USE IN UNAPPROVED INDICATION3,025 reports
WEIGHT INCREASED2,605 reports
DRUG INTERACTION2,342 reports
ANXIETY2,077 reports
CONDITION AGGRAVATED1,789 reports
FATIGUE1,718 reports
SUICIDE ATTEMPT1,653 reports
SUICIDAL IDEATION1,574 reports
PSYCHOTIC DISORDER1,572 reports
SCHIZOPHRENIA1,547 reports
NAUSEA1,540 reports
SOMNOLENCE1,503 reports
AKATHISIA1,441 reports
SEDATION1,417 reports
INSOMNIA1,393 reports
TOXICITY TO VARIOUS AGENTS1,362 reports
DEPRESSION1,343 reports
TREMOR1,342 reports
HEADACHE1,272 reports
DIZZINESS1,266 reports
TREATMENT NONCOMPLIANCE1,224 reports
EXTRAPYRAMIDAL DISORDER1,183 reports
VOMITING1,080 reports
AGITATION1,034 reports
DYSKINESIA1,032 reports
DYSTONIA1,028 reports
HALLUCINATION, AUDITORY1,024 reports
OVERDOSE986 reports
NEUROLEPTIC MALIGNANT SYNDROME982 reports
PAIN965 reports
AGGRESSION956 reports
MALAISE949 reports
NO ADVERSE EVENT893 reports
DRUG ABUSE887 reports
COMPLETED SUICIDE882 reports
DYSPNOEA867 reports
CONFUSIONAL STATE854 reports
DEATH848 reports
ELECTROCARDIOGRAM QT PROLONGED839 reports
DIARRHOEA834 reports
PRODUCT USE ISSUE805 reports
GAMBLING DISORDER791 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION782 reports
HOSPITALISATION781 reports
PRODUCT DOSE OMISSION ISSUE781 reports
DELUSION772 reports
SEXUAL DYSFUNCTION770 reports
TARDIVE DYSKINESIA769 reports
PARKINSONISM757 reports
RESTLESSNESS749 reports
FALL731 reports
ASTHENIA718 reports
ABNORMAL BEHAVIOUR711 reports
PYREXIA698 reports
FEELING ABNORMAL696 reports
INTENTIONAL OVERDOSE696 reports
CONSTIPATION694 reports
MATERNAL EXPOSURE DURING PREGNANCY684 reports
HYPOTENSION681 reports
FOETAL EXPOSURE DURING PREGNANCY668 reports
HALLUCINATION656 reports
IRRITABILITY654 reports
GAIT DISTURBANCE653 reports
NEUTROPENIA653 reports
MENTAL DISORDER649 reports
HYPERTENSION647 reports
UNDERDOSE646 reports
TACHYCARDIA637 reports
BLOOD GLUCOSE INCREASED623 reports
SEIZURE618 reports
MANIA593 reports
OBSESSIVE COMPULSIVE DISORDER579 reports
DEPRESSED MOOD559 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE556 reports
WEIGHT DECREASED556 reports
ARTHRALGIA544 reports
RASH539 reports
HYPERHIDROSIS535 reports
MUSCULOSKELETAL STIFFNESS525 reports
ACUTE KIDNEY INJURY519 reports
PNEUMONIA517 reports
ECONOMIC PROBLEM504 reports
DIABETES MELLITUS500 reports
SEROTONIN SYNDROME500 reports
MENTAL IMPAIRMENT493 reports
EMOTIONAL DISTRESS484 reports
MEDICATION ERROR480 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED477 reports
BLOOD PROLACTIN ABNORMAL471 reports
LEUKOPENIA470 reports
CHEST PAIN460 reports
METABOLIC DISORDER458 reports
INTENTIONAL SELF INJURY455 reports
LOSS OF CONSCIOUSNESS455 reports
MEMORY IMPAIRMENT455 reports
PARANOIA455 reports
HYPERPROLACTINAEMIA450 reports
SLEEP DISORDER448 reports

Report Outcomes

Out of 48,146 classified reports for Abilify Maintena:

  • Serious: 38,455 reports (79.9%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 9,691 reports (20.1%)
Serious 79.9%Non-Serious 20.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female22,738 (54.6%)
Male18,715 (44.9%)
Unknown198 (0.5%)

Reports by Age

Age 23751 reports
Age 32724 reports
Age 35710 reports
Age 30695 reports
Age 29611 reports
Age 49586 reports
Age 24583 reports
Age 22574 reports
Age 16568 reports
Age 28568 reports
Age 37565 reports
Age 17560 reports
Age 52557 reports
Age 27556 reports
Age 25548 reports
Age 36541 reports
Age 19540 reports
Age 44537 reports
Age 21535 reports
Age 26534 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Abilify Maintena?

This profile reflects 96,636 FDA FAERS reports that mention Abilify Maintena. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Abilify Maintena?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, WEIGHT INCREASED, DRUG INTERACTION, ANXIETY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Abilify Maintena?

Labeling and FAERS entries often list Otsuka America Pharmaceutical, Inc. in connection with Abilify Maintena. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Otsuka America Pharmaceutical, Inc.

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with Abilify Maintena:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)ABEMACICLIB (78/100)ABIRATERONE ACETATE (72/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE (65/100)

View all drugs reporting DRUG INEFFECTIVE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsOtsuka America Pharmaceutical, Inc. PortfolioDRUG INEFFECTIVE in Other DrugsOFF LABEL USE in Other DrugsPRODUCT USE IN UNAPPROVED INDICATION in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.